Drug Info:

Donepezil

Brand names: Aricept®, Aricept® ODT

Chemical formula:

Drug Forms:

Donepezil tablets (below)
Donepezil oral solution

Español:

Tabletas de donepezil

Donepezil tablets

What are donepezil tablets?

DONEPEZIL (Aricept®, Aricept® ODT) helps treat the symptoms associated with Alzheimer's disease or dementia. It is not a cure for Alzheimer's disease but offers improvement in memory, attention, reason, language, and the ability to perform simple tasks. Benefits are usually greater for mild to moderate symptoms seen in the early stages of the disease. Generic donepezil tablets or orally-disintegrating tablets are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• asthma or other lung disease
• difficulty passing urine
• head injury
• heart disease, slow heartbeat
• liver disease
• low blood pressure
• Parkinson's disease
• seizures (convulsions)
• severe headaches
• stomach or intestinal disease, ulcers or stomach bleeding
• an unusual or allergic reaction to donepezil, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take donepezil tablets by mouth, refer to the directions below that match the type of tablets you were prescribed. Follow the directions on the prescription label. You may take donepezil with or without food. Take your doses at regular intervals; donepezil is usually taken before bedtime. Do not take your medicine more often than directed. Continue to take your medicine even if you feel better. Do not stop taking except on your prescriber's advice.

Aricept® tablets: Take tablets by mouth. Swallow the tablets with a sip of water or other fluid.

Aricept® ODT tablets: These tablets are made to dissolve in the mouth without having to take them with water. Place the tablet in the mouth and allow it to dissolve, then swallow. While you may take these tablets with water, it is not necessary to do so.

Contact your health care professional regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with donepezil?

• some antibiotics (such as erythromycin and clarithromycin)
• some antidepressants (examples: fluoxetine, fluvoxamine, paroxetine, sertraline)
• some drugs for treating diabetes (pioglitazone, troglitazone)
• atropine
• benztropine
• bosentan
• carbamazepine
• dexamethasone
• dicyclomine
• digoxin
• galantamine
• glycopyrrolate
• hyoscyamine
• ipratropium
• itraconazole or ketoconazole
• medications for motion sickness (examples: dimenhydrinate, meclizine, scopolamine)
• medicines for treating HIV infection or AIDS
• medicines that relax your muscles for surgery
• modafinil
• non-steroidal antiinflammatory drugs (NSAIDs, such as ibuprofen)
• oxybutynin
• phenytoin
• phenobarbital
• propantheline
• quinidine
• rifampin, rifabutin or rifapentine
• rivastigmine
• St. John's wort
• tacrine
• trihexyphenidyl

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking donepezil?

Visit your prescriber or health care professional for regular checks on your progress. Check with your prescriber or health care professional if there is no improvement in your symptoms or if they get worse.

You may get dizzy or feel faint. Do not drive, use machinery, or do anything that needs mental alertness until you know how donepezil affects you.

If you are going to have surgery tell your prescriber or health care professional that you are taking donepezil.

What side effects may I notice from taking donepezil?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• changes in vision or balance
• diarrhea, if it is severe or does not stop
• dizziness, fainting spells, or falls
• increase in frequency of passing urine, or incontinence
• nervousness, agitation, or increased confusion
• skin rash or hives
• slow heartbeat, or palpitations
• stomach pain
• sweating
• uncontrollable movements
• unusual bleeding or bruising, red or purple spots on the skin
• vomiting
• weight loss

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• mild diarrhea, especially when starting treatment
• drowsiness
• headache
• indigestion or heartburn
• loss of appetite
• nausea
• joint pain
• muscle cramping

Where can I keep my medicine?

Keep out of reach of children in a container that small children cannot open.

Store at room temperature between 15 degrees and 30 degrees C (59 degrees and 86 degrees F). Throw away any unused medicine after the expiration date.

Last updated: 1/12/2005 4:09:00 PM

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

Wikipedia: donepezil



Donepezil
Systematic (IUPAC) name
2-[(1-benzyl-4-piperidyl)methyl]- 5,6-dimethoxy-2,3-dihydroinden-1-one
Identifiers
CAS number	120014-06-4
ATC code	N06DA02
PubChem	3152
DrugBank	APRD00039
Chemical data
Formula	C₂₄H₂₉N O₃
Mol. mass	379.492 g/mol
Pharmacokinetic data
Bioavailability	100 (%)
Protein binding	96%
Metabolism	?
Half life	70 hours
Excretion	0,11-0,13 (l/h/kg)
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	Oral tablet, 5 & 10 mg

Donepezil, marketed under the trade name Aricept (Eisai), is a centrally acting reversible acetyl cholinesterase inhibitor. Its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine. It has an oral bioavailability of 100% and easily crosses the blood-brain barrier. Because it has a half life of about 70 hours, it can be taken once a day. Initial dose is 5 mg per day, which can be increased to 10 mg per day after an adjustment period of at least 4 weeks.

Studies in Alzheimer's disease

Currently, there is no definitive proof that use of donepezil or other similar agents alters the course or progression of Alzheimer's disease. However, 6-12 month controlled studies have shown modest benefits in cognition and/or behavior. Pilot studies have reported that donepezil therapy may potentially have effects on markers of disease progression, such as hippocampal volume. Therefore, many neurologists, psychiatrists, and primary care physicians use donepezil in patients with Alzheimer's disease. In 2005, the UK National Institute for Clinical Excellence (NICE) withdrew its recommendation for use of the drug for mild-to-moderate AD, on the basis that there is no significant improvement in functional outcome; of quality of life or of behavioral symptoms. However, NICE revised its guidelines to suggest that donepezil be used in moderate stage patients for whom the evidence is strongest.^[1]

While the drug is currently indicated for mild to moderate Alzheimer's, there is also evidence from 2 trials that it may be effective for moderate to severe disease. An example of this is a Karolinska Institute paper published in The Lancet in early 2006, which states that donepezil improves cognitive function even in patients with severe Alzheimer's disease symptoms. ^[2]

Combinations

Donepezil is sometimes used in combination with Memantine, a newer agent for Alzheimer's disease, as the response to both together is considered superior to donepezil alone. In moderate to severe Alzheimer's, a controlled clinical trial has shown that the addition of Memantine to stable donepezil therapy improves cognition, functioning and behavior.

Uses for other conditions

Donepezil has been tested in other cognitive disorders including Lewy body dementia and Vascular dementia, but it is not currently approved for these indications. Donepezil has also been studied in patients with Mild Cognitive Impairment, schizophrenia, attention deficit disorder, post-coronary bypass cognitive impairment, cognitive impairment associated with multiple sclerosis, and Down syndrome. A 3 year NIH trial in patients with mild cognitive impairment reported that donepezil was superior to placebo in delaying rate of progression to dementia during the initial 18 months of the study but this was not sustained at 36 months. In a secondary analyses, a subgroup of individuals with the Apolipoprotein E4 genotype showed sustained benefits with donepezil throughout the study. However at this time donepezil is not indicated for prevention of dementia.

Relationship to class and placebo

Donepezil is generally better tolerated than others in its class, simpler to use, and the agent with the most number of well controlled clinical trials. Common side effects include bradycardia, nausea, diarrhea, anorexia, abdominal pain, and vivid dreams. In 2006, Eisai, the manufacturer issued a statement that a single vascular dementia study found a difference in the percent of study participants who died in the donepezil group (1.7%) versus the placebo group (0%) and that this could be due to an unusually low death rate on the placebo group. An analysis of all three Vascular Dementia trials, according to Eisai, "shows no statistically significant differences in observed mortality rates between the donepezil and placebo groups (1.7% vs. 1.1%)".

Pilot study

In July 2002, a pilot study, reported that donepezil improves the memory of aging pilots. The researchers trained pilots in a flight simulator to perform specific maneuvers and to respond to emergencies that developed during their mock flight, after giving half the pilots donepezil and half a placebo. One month later they retested the pilots and found that those who had taken the donepezil remembered their training better, as shown by improved performance.^[3] However, several other studies in normal older adults (before and after the above study) have not shown any significant cognitive improvements or shown inconsistent findings.^{[citation needed]}

References

^ Xiong G, Doraiswamy PM (2005). "Combination drug therapy for Alzheimer's disease: what is evidence-based, and what is not?". Geriatrics 60 (6): 22-6. PMID 15948662.
^ Drug 'treats severe Alzheimer's'. Retrieved on 2007-07-24.
^ Yesavage JA, Mumenthaler MS, Taylor JL, et al (2002). "Donepezil and flight simulator performance: effects on retention of complex skills". Neurology 59 (1): 123-5. PMID 12105320.

Brenner, G. M. (2000). Pharmacology. Philadelphia, PA: W.B. Saunders Company. ISBN 0-7216-7757-6
Canadian Pharmacists Association (2000). Compendium of Pharmaceuticals and Specialties (25th ed.). Toronto, ON: Webcom. ISBN 0-919115-76-4

External links

Official Aricept product site [1]

Anticholinesterases (N06DA, N07AA)
Carbamates	Ambenonium - Demecarium - Stigmine (Neostigmine, Physostigmine, Pyridostigmine, Rivastigmine)
Other	Galantamine - Metrifonate - Donepezil - Tacrine - Edrophonium

Psychoanaleptics: anti-dementia drugs (N06D)
Anticholinesterases	Tacrine - Donepezil - Rivastigmine - Galantamine
Other	NMDA receptor antagonist (Memantine) - Ginkgo biloba

This entry is from Wikipedia, the leading user-contributed encyclopedia. It may not have been reviewed by professional editors (see full disclaimer)

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